Medical device licence · 63212 · Class 4
ABBOTT PRISM SYSTEM
No longer licensed: cancelled
Licence status Cancelled; first licensed November 14, 2003; ended April 11, 2023. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 63212
- Licence holder
- Abbott Laboratories Diagnostics DivisionAbbott Park, IL, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- November 14, 2003
- Ended
- April 11, 2023
- Devices covered
- 22
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ABBOTT PRISM SYSTEM - HBCORE ASSAY KIT (DONOR SCREENING)
- ABBOTT PRISM SYSTEM - HBCORE WASH KIT
- ABBOTT PRISM SYSTEM - HCV ASSAY KIT (DONOR SCREENING)
- ABBOTT PRISM SYSTEM - HCV WASH KIT
- PRISM SYSTEM - ANALYZER (REFURBISHED)
- PRISM SYSTEM - ANALYZER - CLASS 4
- PRISM SYSTEM - CHAGAS ASSAY KIT (DONOR SCREENING/CADAVERIC)
- PRISM SYSTEM - HBSAG CONFIRMATION ASSAY
- PRISM SYSTEM - HIV O PLUS (DONOR SCREENING)
- PRISM SYSTEM - HIV O PLUS WASH KIT
- PRISM SYSTEM - HTLV-I/HTLV-II ASSAY KIT (DONOR SCREENING)
- PRISM SYSTEM - HTLV-I/HTLV-II WASH KIT
- PRISM SYSTEM - ON-BOARD REAGENTS
- PRISM SYSTEM - POSITIVE RUN CONTROL KIT
- PRISM SYSTEM - PRISMNEXT SOFTWARE
- PRISM SYSTEM - PRISMNEXT SYSTEM
- PRISM SYSTEM - PRISMNEXT UPGRADE KIT
- PRISM SYSTEM - RUN CONTROL KIT
- PRISM SYSTEM - SOFTWARE
- PRISM SYSTEM HBSAG ASSAY KIT (DONOR SCREENING)
- PRISM SYSTEM HBSAG CONFIRMATORY KIT
- PRISM SYSTEM RUN CONTROL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.